HAND SANITIZER- alcohol liquid

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HANUL CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that can cause disease.

Warnings

For external use only: hands. Flammable. Keep away from fire or flame

WHEN USING

When using the product keep out of eyes. In case of contact with eyes flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

STOP USE

Stop use and ask a doctor if irritation or redness develops condition persists for more than 72 hours

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Place enough product to hands to cover all surface

Rub hands together until dry

Not recommended for infants

Other information

do not store above105°F/40°C

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

Water. Glycerin, Hydrogen peroxide, Carbomer, Aminomethyl Propanol, Fragrance

Package Label - Principal Display Panel

500 mL NDC: 75214-502-50

Rico

Hand sanitizer

non-sterile solution

80% alcohol antiseptic

kill 99.9% germs of common illness-causing germs

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75214-502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.13 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	17.68 mL  in 100 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	0.4 mL  in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.3 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75214-502-50	500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - HANUL CO.,LTD (557814370)

Establishment
Name	Address	ID/FEI	Business Operations
HANUL CO.,LTD		557814370	manufacture(75214-502)